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| FILE - In a Thursday, Oct. 4, 2012 file photo, a delivery man walks up to the door of New England Compounding in Framingham, Mass. Federal and state investigators have been tightlipped about any problems they may have seen at the pharmacy whose steroid medication has been linked to a lethal outbreak of a rare fungal form of meningitis, or whether they have pinpointed the source of the contamination. They did disclose Thursday, Oct. 11, 2012 that they found fungus in more than 50 vials from the company. |
NEW YORK (AP) -- Was it some moldy ceiling tiles? The dusty shoes of a careless employee? Or did the contamination ride in on one of the ingredients?
There
are lots of ways fungus could have gotten inside the Massachusetts
compounding pharmacy whose steroid medication has been linked to a
lethal outbreak of a rare fungal form of meningitis.
The
outbreak has killed at least 15 people and sickened more than 200
others in 15 states. Nearly all the victims had received steroid
injections for back pain.
Federal and state
investigators have been tightlipped about any problems they may have
seen at the New England Compounding Center or whether they have
pinpointed the source of the contamination. They did disclose last week
that they found fungus in more than 50 vials from the pharmacy.
Company
spokesman Andrew Paven said by email that criminal investigators from
the Food and Drug Administration were at the pharmacy in Framingham,
Mass., on Tuesday. The visit was part of a broad federal and state
investigation of the outbreak, FDA spokesman Steven Immergut said in an
email.
New England Compounding has not
commented on its production process or what might have gone wrong, so
outside experts can only speculate. But the betting money seems to be on
dirty conditions, faulty sterilizing equipment, tainted ingredients or
sloppiness on the part of employees.
The drug
at the center of the investigation is made without preservative, meaning
there's no alcohol or other solution in it to kill germs such as a
fungus. So it's very important that it be made under highly sterile
conditions, experts said.
Compounding
pharmacies aren't as tightly regulated as drug company plants, but they
are supposed to follow certain rules: Clean the floors and other
surfaces daily; monitor air in "clean rooms" where drugs are made;
require employees to wear gloves and gowns; test samples from each lot.
The
rules are in the U.S. Pharmacopeia, a kind of national standards book
for compounding medicines that's written by a nonprofit scientific
organization. Most inspections, though, are handled by state boards of
pharmacy. Massachusetts last inspected New England Compounding in March
in response to a complaint unrelated to the outbreak; the results have
not been released.
High-volume production of
the sort that went on at New England Compounding also raises the chances
of contamination, experts said.
Traditionally,
compounding pharmacies fill special orders placed by doctors for
individual patients, turning out maybe five or six vials. But many
medical practices and hospitals place large orders to have the medicines
on hand for their patients. That's allowed in at least 40 states but
not under Massachusetts regulations.
Last
month, New England Compounding recalled three lots of steroids made
since May that totaled 17,676 single-dose vials of medicine - roughly
equivalent to 20 gallons.
"I don't see it as
appropriate for a community pharmacy to do a batch of something
preservative-free in numbers in the thousands" of doses, said Lou
Diorio, a New Jersey-based consultant to compounding pharmacies. Diorio,
who has no connection to the investigation or the company, said it is
harder to keep everything sterile when working with large amounts.
To
make the steroid, a chemical powder from a supplier is mixed with a
liquid, sterilized through heating, then pumped into vials, according to
Eric Kastango, another consultant from New Jersey who helps compounding
pharmacies deal with contamination problems. He is not connected to the
company either.
Perhaps the powder was
contaminated, either at New England Compounding or another location.
Maybe the fungus was in the liquid, some experts said.
Kastango
offered additional possible scenarios, related to the large volume
produced: Making thousands of doses at a time can take many hours or
days. It's possible that a batch could sit for hours or even a day or so
before being placed in vials, making it vulnerable to contamination, he
said.
It's also likely a pharmacy worker
would take a break to get a snack or cup of coffee, to go to the
bathroom or to step outside for a smoke, Kastango explained. If the
person hurried back and didn't properly wash up or put on new gowns,
masks and other safety garb, that could introduce contamination.
Faulty
or misused sterilizing equipment is also a possibility. After a 2002
fungal meningitis outbreak linked to a South Carolina compounding
pharmacy, investigators discovered that a piece of sterilizing equipment
called an autoclave had been improperly used by the staff.
The
types of fungus in the latest outbreak are ubiquitous: The first to be
identified was Aspergillus, commonly found indoors and outdoors. As more
testing of patients was completed, it became clear that another fungus -
a black mold called Exserohilum - caused most of the illnesses.
Exserohilum is common in dirt and grasses.
Most
people do not get sick from ordinary exposure to these kinds of fungus,
but spinal injections can provide them a pathway into the brain.
Doctors are generally leery of using spinal steroid injections that
contain preservatives because of fears the preservatives themselves can
cause side effects.
Whatever happened at New England Compounding, it probably wasn't unique.
Just
last year, there were at least three apparently similar incidents: At
least 33 patients suffered fungal eye infections traced to products made
by a compounding pharmacy in Ocala, Fla.; at least a dozen Florida
patients were blinded or damaged in an outbreak linked to a compounder
in Hollywood, Fla.; and the deaths of nine Alabama patients were
attributed to tainted intravenous nutritional supplement provided by a
compounder in Birmingham.
"These events have
been happening once or twice a year for the last 15 years," Kastango
said. "We wouldn't tolerate this if a plane crashed once or twice a
year. But in health care, we've grown desensitized to these kinds of
problems."
